Scientists Advancing Affordable Medicines, Inc. is a nonprofit 501(c)(6) organization that seeks to provide a dedicated platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. Because we are sharing approaches now for the affordable medicines of tomorrow, we have adopted the tradename SAAMnow.
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Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Financing Complexities
Our next workshop, which will be held in Philadelphia on October 16-18, 2019, is focused on understanding and correctly characterizing the 505(b)(2) pathway, while debunking the rampant misconceptions circulating in the pharmaceutical industry. Additionally, the agenda will look at how value-added medicines created through the 505(b)(2) pathway may, with focused upfront planning, satisfy other regulatory authorities, like EMA, allowing them to be parlayed into global marketing opportunities. For SAAMnow, this is a unique workshop in which we will extend our reach beyond just science by collaborating with a complimentary non-profit organization, The 505(b)(2) Platform with a synergistic remit. Our speakers, panelists, moderators and invited FDA will address the science, regulatory, legal, and financing components that are crucial to the successful development and launch of a 505(b)(2) product.
Join us in demystifying 505(b)(2) Development!
SAAMnow offers individuals the opportunity to potentially impact the availability of affordable medicines through cutting-edge research. SAAMnow is looking for individuals involved/interested in research & development, formulation/manufacturing science, analytical chemistry, clinical science, statistics, quality systems, regulatory science, marketing, and allied disciplines associated with the development, manufacturing, testing, and commercialization of high quality affordable medicines. Affordable medicines are broadly defined as those that take advantage of abbreviated regulatory filing pathways, resulting in development cost savings that can then be passed on to patients. Examples include conventional generic pharmaceuticals, biosimilars, and products filed via hybrid regulatory pathways, such as the 505(b)(2) route.